TetraKit Technologies (TT) is developing the TetraKit Platform, a universal radiolabelling platform that enables the synthesis of novel therapeutic and diagnostic (theranostic) radiopharmaceuticals (RPs). By overcoming the limitations of currently available radiochemistry solutions, TT will address the unmet need for an innovative approach that makes radiolabeling, specifically with radiohalogens, simple, rapid, effective and scalable. Based on an ultrafast next generation tetrazine ligation and linker technology, the TetraKit Platform allows labelling of any biomolecule (target vector) with any radiohalogen or radiometal, according to a versatile ‘plug-and-play’ principle. As such, TT will facilitate unleashing the full potential of novel theranostic RPs to serve the need of millions of cancer patients worldwide. To validate the TetraKit Platform, TT seeks EIC Accelerator blended financing to advance the clinical development of the lead asset emerging from the platform, 131I-DualFAPi, an iodine-131-labelled therapeutic RP that targets the fibroblast activation protein (FAP) – THE ‘next billion-dollars theranostics target’. Initially to be developed for the treatment of metastasized Triple Negative Breast Cancer (TNBC), an aggressive type of cancer with poor survival chances, TT’s lead asset will be the first radiohalogenated FAP-targeting therapeutic RP in clinical development, made possible by the TetraKit Platform. Completion of a Phase 1/2 program in TNBC patients will present a significant value inflection point for TT, which is anticipated to result in a strategic partnership for the final development and commercialization steps. Successful development of 131I-DualFAPi will be an essential milestone that will allow TT to fully exploit the TetraKit Platform, bringing immense commercial and societal value.

TetraKit Technologies (TT) is developing the TetraKit Platform, a universal radiolabelling platform that enables the synthesis of novel therapeutic and diagnostic (theranostic) radiopharmaceuticals (RPs). By overcoming the limitations of currently available radiochemistry solutions, TT will address the unmet need for an innovative approach that makes radiolabeling, specifically with radiohalogens, simple, rapid, effective and scalable. Based on an ultrafast next generation tetrazine ligation and linker technology, the TetraKit Platform allows labelling of any biomolecule (target vector) with any radiohalogen or radiometal, according to a versatile ‘plug-and-play’ principle. As such, TT will facilitate unleashing the full potential of novel theranostic RPs to serve the need of millions of cancer patients worldwide. To validate the TetraKit Platform, TT seeks EIC Accelerator blended financing to advance the clinical development of the lead asset emerging from the platform, 131I-DualFAPi, an iodine-131-labelled therapeutic RP that targets the fibroblast activation protein (FAP) – THE ‘next billion-dollars theranostics target’. Initially to be developed for the treatment of metastasized Triple Negative Breast Cancer (TNBC), an aggressive type of cancer with poor survival chances, TT’s lead asset will be the first radiohalogenated FAP-targeting therapeutic RP in clinical development, made possible by the TetraKit Platform. Completion of a Phase 1/2 program in TNBC patients will present a significant value inflection point for TT, which is anticipated to result in a strategic partnership for the final development and commercialization steps. Successful development of 131I-DualFAPi will be an essential milestone that will allow TT to fully exploit the TetraKit Platform, bringing immense commercial and societal value.

Accelerate.EU, a collaborative European initiative, envisions revolutionising theranostics through innovative targeted alpha-therapies (TATs) using astatine-211. A unique consortium will combine diagnostics with potent cytotoxic effects of alpha-particles to enable precise tumour radiation while minimising side effects. Accelerate.EU's core objectives are: Innovate theranostic solutions based on therapeutic and diagnostic pairs for hard-to-treat cancers, exploring the potential for simultaneous preclinical studies and early-phase clinical trials (i.e. co-clinical approach) to showcase the enhanced benefits of these approaches for cancer patients. • Establish a robust and sustainable EU manufacturing and treatment infrastructure for astatine-211, ensuring compliance with quality assurance and regulatory guidelines while streamlining the supply chain across the EU. • Produce comprehensive educational and training content to support the deployment of theranostic solutions, fostering knowledge dissemination, transfer and longevity/durability Accelerate.EU strategically develop TATs to address unmet clinical needs in pancreatic, breast, and brain cancers. The co-clinical approach, incorporating concurrent clinical and preclinical studies, adds a breakthrough dimension to theranostics. Accelerate.EU pioneers 211At-theranostics establishing a resilient EU scale-up production network and empowering healthcare providers to offer TATs to cancer patients. Through the collaboration of experts from academia, industry and regulatory agencies, Accelerate.EU's implements a visionary approach addressing clinical gaps, accelerating TAT theranostic development, supporting EU global leadership, with primary target to improve patient outcomes for lasting impact on EU cancer care.